Study to Evaluate Efficacy of Shunt Operation for Idiopathic Normal Pressure Hydrocephalus

Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan (Other)

Overall Status

Completed

CT.gov ID

NCT00221091

Collaborator

Codman & Shurtleff (Industry), Johnson & Johnson (Industry), NIHON MEDI-PHYSICS CO.,LTD. (Other), Daiichi Pharmaceuticals (Industry), Eisai Limited (Industry)

110

Enrollment

Location

Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the efficacy of shunt operation for idiopathic normal pressure hydrocephalus, and determines the diagnostic value of noninvasive procedures commonly practiced in the clinic.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Normal Pressure Hydrocephalus	Procedure: ventriculo-peritoneal shunt	Phase 2

Detailed Description

Idiopathic normal pressure hydrocephalus (iNPH) is a syndrome characterized by ventricular dilatation due to disturbed cerebrospinal fluid (CSF) circulation, accompanied by gait disturbance, dementia and/or urinary incontinence without causative disorders. With the aging of Japanese society, the number of patients is increasing, requiring diagnostic and therapeutic guidelines for the improvement of the patients' quality of life and social care. Under such conditions, this project was made as the prospective study of iNPH on Neurological Improvement (SINPHONI ). This study aims 1) to establish methods for non-invasive diagnosis of iNPH, and 2) to demonstrate therapeutic outcome of shunting operation by Codman Hakim programmable valve (CHPV). In this protocol, the evaluation of validity on MRI, tap test, CT cisternography, and CBF (3D-SSP) will be done in the diagnosis, and manual of initial setting pressure in CHPV for prevention of overdrainage problems will be estimated by modified Rankin scale (as primary endpoint) and some another scales during 1 year.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Study of Idiopathic Normal Pressure Hydrocephalus for Neurological Improvement

Study Start Date :

Sep 1, 2004

Study Completion Date :

Oct 1, 2005

Outcome Measures

Primary Outcome Measures

modified Rankin scale []

Secondary Outcome Measures

cognitive function, NPH grading scale []

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who had at least one more points of the triad (gait disturbance, cognitive impairment, and urinary incontinence) in Japan NPH grading scale revised, and had disproportionate ventriculomegaly (Evans index >0.3) with closing of the CSF space at high convexity on MRI. These patients must be diagnosed clinically other causative disorders, and ventricular dilatation due to disturbance of the cerebrospinal fluid (CSF) circulation. Be able to give informed consent.

Exclusion Criteria:

Cannot have an MRI scan 2) Has a problem with bleeding tendency and other serological examination. (liver enzyme and renal dysfunction, blood coagulopathy, and etc.) 3) Is unable to understand the risks of the testing and surgical therapy. 4) is tolerable for one year follow up after shunting operation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Noto General Hospital	Nanao-shi	Ishikawa Pref.	Japan	926-8610

Sponsors and Collaborators

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Codman & Shurtleff
Johnson & Johnson
NIHON MEDI-PHYSICS CO.,LTD.
Daiichi Pharmaceuticals
Eisai Limited

Investigators

Principal Investigator: Masatsune Ishikawa, M.D., Department of Neurosurgery, kitano Hospital, The Tazuke Kofukai Medical Research Institute. City: Osaka